Family Care Hydrocortisone

Description

Hydrocortisone is a white to practically white, odorless, crystalline powder. It has a solubility profile that includes solubility in alcohol, chloroform, and ether, while being slightly soluble in water and practically insoluble in hexane. The formulation may contain inactive ingredients such as citric acid, sodium citrate, sodium chloride, and water for injection. The product is packaged in a carton that is labeled with the brand name and dosage information.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. It should be applied no more than 3 to 4 times daily.

Use in children under 2 years of age is not recommended; consultation with a healthcare professional is advised prior to use in this population.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients presenting with vaginal discharge should not use this product and should consult a healthcare professional.

• The product should not be applied prior to treating diaper rash.

• It is contraindicated for use in children under 2 years of age.

Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, the product should be discontinued and a healthcare professional consulted. Furthermore, this product should not be used concurrently with any other hydrocortisone product without prior medical advice.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to consult their doctor before initiating the use of any other hydrocortisone product.

Side Effects

Patients should be aware that this product is for external use only and should avoid contact with the eyes.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice before starting any other hydrocortisone product to prevent potential adverse reactions or interactions.

Drug Interactions

Before initiating treatment with any hydrocortisone product, it is imperative to consult a healthcare professional. This precaution is essential to ensure safe and effective use, as potential interactions with other medications may exist.

Currently, there are no specific drug or laboratory test interactions documented in the available data. However, healthcare providers should remain vigilant and monitor for any unforeseen interactions that may arise during the course of treatment.

Packaging & NDC

Below are the non-prescription pack sizes of Family Care Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product for the treatment of diaper rash and should consult a doctor if such a condition is present. For children under 2 years of age, it is advised to consult a doctor before use.

For pediatric patients aged 2 years and older, the product may be applied to the affected area no more than 3 to 4 times daily. Caution is advised when considering use in younger children, and medical guidance is essential.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific pregnancy-related warnings, precautions, or dosage modifications associated with the use of FAMILY CARE HYDROCORTISONE (hydrocortisone cream) during pregnancy. Available data does not indicate any known risks to fetal outcomes when this medication is used as directed. However, healthcare professionals should consider the benefits and potential risks when prescribing this medication to pregnant patients. It is advisable for women of childbearing potential to discuss their treatment options with their healthcare provider to ensure appropriate management during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential risks associated with overdosage.

Symptoms indicative of an overdose may encompass severe skin irritation, among other serious side effects. Healthcare professionals should be vigilant in monitoring for these symptoms and act accordingly to ensure patient safety.

Management of an overdose should involve supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is essential to address any complications that may arise.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should emphasize the importance of reading all label directions before using the medication. Patients should be encouraged to retain the carton, as it contains important information that may be necessary for their safety and proper use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a Lot Number and Expiration Date, which can be found on the box or the crimp of the tube. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Proper handling should be observed to ensure the product remains within the specified storage conditions.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use.

Clinicians should counsel patients to read all label directions prior to using the medication and to retain the carton, as it contains important information. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Family Care Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)